More information about Anti-Vitamin Regulations

Codex Guidelines for Vitamins and Minerals - Optional or Mandatory?

By Paul Anthony Taylor

Introduction

March 2004 – The Codex Alimentarius Guidelines for Vitamin and Mineral Supplements are a joint attempt by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) to formulate one single standard governing the sale of food supplements that can be applied throughout the global market. Under the guise of free trade ‘harmonization’ the Guidelines are being drawn up by the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU), where vitamins and minerals are defined as foods. This committee meets in Germany once every year, usually in November.

Although the Guidelines have gone through several revisions over recent years it is now becoming increasingly clear that their eventual effect, once completed and implemented, may be to remove large numbers of the most effective forms of nutrients from the global market; set restrictive upper limits on the dosages of all permitted nutrients; and prevent the sale of all supplements for curative, preventative or therapeutic purposes without a doctor’s prescription. As a result, the Guidelines would continue to ensure that the sale of curative, preventative and therapeutic products remains the exclusive province of the pharmaceutical industry.

As this article will show, the Codex Alimentarius Guidelines for Vitamin and Mineral Supplements are now without question the most serious of all the various threats currently facing the global natural products industry.

A brief history of Codex

The Codex Alimentarius Commission was established in 1963 following resolutions passed at the Eleventh Session of the Conference of the Food and Agriculture Organization of the United Nations in 1961, and at the Sixteenth World Health Assembly in 1963. (1). The historical origins of Codex Alimentarius lie in the Codex Alimentarius Austriacus however, which was a collection of standards and product descriptions for a wide variety of foods, developed in the Austro-Hungarian Empire between 1897 and 1911. (2). Austria subsequently actively pursued the creation of a regional food code, the Codex Alimentarius Europaeus, or European Codex Alimentarius, between 1954 and 1958. (3). The Council of the Codex Alimentarius Europaeus then adopted a resolution in 1961 proposing that its work on food standards be taken over by the FAO and the WHO. (4).

The relationship between Codex Alimentarius and the WTO

The WTO replaced the General Agreement on Tariffs and Trade (GATT) on 1 January 1995. The GATT itself had been in existence since 1947, as the organization overseeing the multilateral trading system. (5). The governments that had signed GATT were officially known as “GATT contracting parties”, and upon signing the new WTO agreements (which include the updated GATT, known as GATT 1994), they officially became known as “WTO Members”. Built upon some of the ideas and principles that underpin the European Union (6), the WTO currently has a total membership of 146 countries. (7). In the mid-1990s Codex Alimentarius signed agreements with the WTO by which Codex creates trade standards that the WTO uses to resolve international trade disputes. (8), (9), (10).

Codex is effectively mandatory for all WTO Members

The legal basis for enforcement of the various different Guidelines and Standards created by Codex comes from the ‘Agreement on the Application of Sanitary and Phytosanitary Measures’ (SPS Agreement) and the ‘Agreement on Technical Barriers to Trade’ (TBT Agreement). Both the SPS Agreement and the TBT Agreement were included among the Multilateral Agreements on Trade in Goods, which was annexed to the 1994 Marrakesh Agreement that established the WTO. (11). Although Codex standards and guidelines are theoretically voluntary, a new status has in effect been conferred on them by the SPS Agreement, in that any WTO Member adopting them is presumed to be in full compliance with the SPS Agreement. (12).

The net result of this is that even when a country decides not to use a Codex standard the measure that it operates in place of that Codex standard remains subject to a range of conditions set out in detail in Article 5 of the SPS Agreement. (13). The most important of these conditions is a requirement to take into account risk assessment techniques developed by “the relevant international organizations”. (14). As it turns out however these “relevant international organizations” actually include Codex itself, and in this respect it is notable that the CCNFSDU is already considering a document entitled ‘Discussion Paper on the Application of Risk Analysis Applied to the Work of the CCNFSDU’. (15). In other words, in the event of a country choosing not to implement a Codex standard the measure that it operates in place of that standard still remains subject to Codex guidelines.

Other conditions affecting measures that countries operate in place of Codex standards include a requirement to take into account economic factors and the relative cost-effectiveness of alternative approaches to limiting risks (16); a requirement to take into account the objective of minimizing negative trade effects (17); and a requirement to avoid arbitrary or unjustifiable distinctions in the levels of risk protection that it considers to be appropriate in different situations, if such distinctions result in discrimination or a disguised restriction on international trade (18).

As such then, countries that are members of the WTO are effectively required to implement all Codex standards by virtue of the fact that they have signed up to the SPS Agreement. It may not be entirely coincidental therefore that many countries have already begun taking steps to implement stringent restrictions upon the dosage and availability of vitamins and minerals, in preparation for the finalisation of the Codex Guidelines for Vitamin and Mineral Supplements. Indeed, the significance of Codex was underscored in 1985 by United Nations Resolution 39/85, whereby guidelines were adopted on consumer protection policies. The guidelines advise that "Governments should take into account the need of all consumers for food security and should support and, as far as possible, adopt standards from the ... Codex Alimentarius". (19).

Codex texts are used by the WTO to resolve international trade disputes

Whilst it may be technically true for the WTO to say that “there is no legal obligation on Members to apply Codex standards, guidelines and recommendations” (20), the reality is that Codex texts are used by the WTO as a means of resolving international trade disputes (21), and WTO Members are legally obliged to abide by WTO rulings. Once the Codex Guidelines for Vitamin and Mineral Food Supplements are completed therefore, all it would take to begin enacting them globally would be for one of the participating countries to launch, and win, an international trade dispute. The global adjudicators in such an instance would be the WTO Dispute Settlement Body (22), some of the hearings for which take the form of closed meetings held in private. Appeals to Dispute Settlement Body rulings are possible, but they have to be based on points of law such as legal interpretation — they cannot re-examine existing evidence or examine new issues. (23).

The WTO does not distinguish between ‘Standards” and ‘Guidelines’

Theoretically, there are three levels of acceptance for Codex texts, namely; ‘full acceptance’; ‘acceptance with specified deviations’; and ‘free distribution’ (which means that the country concerned undertakes that products conforming with a Codex Standard may be distributed freely within its territorial jurisdiction, while domestically produced products sold within its own borders remain unaffected). (24). The ‘free distribution’ option has led many people to mistakenly believe that Codex does not have the authority to impose anything on a country in terms of domestically produced products sold into its own internal market. However, because Codex standards are used by the WTO to resolve international trade disputes, WTO members can literally have Codex Guidelines and Standards forced upon them, irrespective of acceptance. Proof of this comes from the Codex Committee on General Principles, who have stated the following:

The Committee recognized that the current procedures had not been used frequently and recalled that Codex standards were a reference in the framework of the WTO Agreements irrespective of acceptance. (25).

Furthermore, in response to a request from the 22nd Session of the Codex Alimentarius Committee for the WTO Committee on Samitary and Phytosanitary Measures (the SPS Committee) to clarify “how the Committee would differentiate standards, guidelines or recommendations in relation to the implementation of the SPS Agreement" by WTO Members, the WTO has informed Codex that the SPS Agreement does not differentiate between standards and guidelines (26), (20), and that how a Codex text is applied depends upon its substantive content rather than the category of the text. (20). Clearly then, any distinction between ‘Standards’ and ‘Guidelines’ by the Codex Alimentarius Committee is purely arbitrary.

The growing influence of the EU upon Codex

The EU is the single most powerful influence upon the Codex discussions, and a recent European Council document has acknowledged the increased legal relevance that the various Codex Alimentarius standards, guidelines and recommendations have acquired “by virtue of the reference made to the Codex Alimentarius in the WTO Agreements and the presumption of conformity which is conferred on relevant national measures when they are based on such standards, guidelines or recommendations adopted by the Codex Alimentarius Commission.” (27). Similarly, this document also acknowledges that one of the objects of the Codex Alimentarius Commission is to harmonise worldwide health standards. (28).

It now appears increasingly likely that EU health policy will gradually become the blueprint for global health policy. The growing similarities between the text of the EU Food Supplements Directive (29) and the Codex Draft Guidelines for Vitamin and Mineral Supplements (30), for example, are no coincidence. Basil Mathioudakis, who was responsible for drafting the text of the EU Food Supplements Directive, is the head of the European Commission delegation at Codex, and will now be representing 25 EU countries at the next Codex meeting in Bonn in November 2004 (due to the 10 new countries who will be joining the EU on 1st May 2004). Moreover, the EU will shortly have full membership status at Codex. (31). The net result of this is that Mr. Mathioudakis, on behalf of the EU Commission, will now be entitled to wield a number of votes at Codex equal to the number of its Member States that are present at the time the vote is taken. (32). Furthermore, whenever Mr. Mathioudakis exercises his right to vote, the Member States will not be entitled to exercise theirs. (33). As such, the EU Member States are now virtually powerless to oppose the EU Commission at Codex; especially so given the fact that the majority of the guidelines being drawn up are either already law, or about to become law, in their own countries.

The likely acceleration of the Codex adoption process

Although formal votes are rarely taken at Codex, both the FAO and the EU are now in favour of a majority of two-thirds being sufficient in future for a Codex text to be adopted. (34). Democratically of course, since the EU, with its soon-to-be population of 450 million people (35), is allowed 25 votes at Codex, then the United States, with its population of over 280 million people (36), should proportionately be given at least 15 votes. Under the present system however, the United States is only allowed one vote, which means that the EU is now in an extremely powerful position. In fact, at the next Codex meeting it is very likely that the EU will be able to wield a block vote consisting of almost one half of all of the countries who are likely to attend. As such, only another 12 more votes would be needed over and above the EU’s 25 votes to reach a two-thirds majority. (37). Because only one country, South Africa, is actively opposing these restrictive proposals for the world-wide availability of vitamins and mineral supplements, the global future for natural healthcare now lies at a critical juncture.

Furthermore, both the FAO and the EU have recently stated their desire to accelerate the work of Codex (38), and have agreed that the present 8-step procedure should be ‘simplified’ to a 5-step procedure. (39). Nevertheless, it should be borne in mind that in order to achieve an adoption in 5 steps it may not even be necessary to modify the existing procedures, as these already provide for an accelerated adoption. (40), (41). The Codex Alimentarius Commission can authorise, for example, on the basis of a two-thirds majority of votes cast, the omission of Steps 6 and 7, whenever such an action is recommended by the relevant Codex Committee (42).

The Codex threat to the Food Supplements Directive legal challenges

The Food Supplements Directive (29) was passed by the EU Parliament on 13th March 2002, and entered into law in the EU Member States on 1st August 2003. Its text and intent are remarkably similar to that of the Codex Draft Guidelines for Vitamin and Mineral Supplements (30), as its effect, when it becomes fully implemented on 1st August 2005, will be to remove large numbers of the most effective forms of nutrients from the EU market; set restrictive upper limits on the dosages of all nutrients permitted in the EU; and prevent the sale of all supplements for curative, preventative or therapeutic purposes within the EU without a doctor’s prescription.

Two legal challenges to the validity of this Directive have now been launched by groups from the UK; one by the Alliance for Natural Health (43) in conjunction with Nutri Link Ltd. (44), and the other by the Health Food Manufacturers Association (45) in conjunction with the National Association of Health Stores (46). Both of these challenges have recently been referred to the European Court of Justice (ECJ), following a High Court hearing that took place in London on 30th January 2004. The judge at the hearing, Mr Justice Richards, ruled that there was an arguable case that the Food Supplements Directive was unlawful; that a reference to the ECJ was plainly appropriate; and that it should be made as soon as possible. (47).

However, because of the strength of the EU block-vote at Codex it is possible that discussions regarding the Codex Draft Guidelines for Vitamin and Mineral Supplements might even be completed at this year’s CCNFSDU meeting in November. Such an outcome could have grave implications for the legal challenges to the EU Food Supplements Directive, because if the Codex Guidelines were agreed before the legal challenge was completed the UK lawyers would in essence be arguing for the European Court of Justice to overturn legislation that was fully in line with a newly agreed global standard.

Nevertheless, the legal challenges currently being mounted against the EU Food Supplements Directive are unquestionably crucial to the future of health freedom in the EU, and their eventual success could buy valuable time for the growing European health freedom movement, as well as strike a blow against the text of what is in effect an EU blueprint for the global regulation of supplements. However, it should not be forgotten that from the regulatory perspective Codex is the trump card. Even if the legal challenges to the Food Supplements Directive are successful, for example, the Codex proposals could still be implemented as the global standard, thus effectively overruling any short-term victory for health freedom in the EU.

Conclusion

As a result of the SPS Agreement, Codex texts, guidelines and standards are effectively mandatory for all WTO Members. Also, because the WTO do not distinguish between guidelines and standards, and the fact that the WTO uses Codex texts to resolve international trade disputes, a finalised Codex text would have the ability to override the dietary supplement laws of all countries - including the United States and its hard-fought victory in passing DSHEA. Moreover, although the Codex Guidelines for Vitamin and Mineral Food Supplements are currently at step 5 of an 8-step finalisation process, the EU and the FAO have both recently stated their desire to accelerate the work of Codex such that the adoption of Codex texts could henceforth be achieved in 5 steps. However, and as previously stated, in order to achieve an adoption in 5 steps it may not even be necessary to modify the existing procedures, as these already provide for an accelerated adoption. As a result of the stranglehold that the EU are beginning to exert upon the Codex Alimentarius discussions this outcome therefore remains a very real possibility for the next CCNFSDU meetings in November 2004.

In summary the EU is now the single strongest influence at Codex meetings, and the EU Food Supplements Directive is essentially the blueprint for the Codex Guidelines for Vitamin and Mineral Supplements. Unless serious changes are made to the way in which Codex operates therefore, it would not be unreasonable to expect that other EU health-related legislation, such as restrictive regulations on nutrition and health claims, will become the blueprints for still further standards to be enacted on a globally harmonised basis. In the event of this the planetary effects upon natural health, and by implication public health, would be both profound and disastrous.

37. Forty eight countries attended the Codex Committee on Nutrition and Foods for Special Dietary Uses 25th Session, held at the Bruckenforum, Bonn, Germany, from 3-7 November 2003. ALINORM04/26.
See ftp://ftp.fao.org/codex/alinorm04/al04_26e.pdf
These forty eight countries included three of the new EU countries (Hungary, Poland and Slovenia). If the other seven new EU countries attend the next meeting in November 2004 (and assuming that every country that attended last year also attends) there will be fifty five countries attending in total. A two thirds majority would therefore consist of thirty seven votes. The EU will have twenty five votes.